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ROLE OF NICOTINE GUMS, NICOTINE PATCHES AND BEHAVIOURAL COUNSELLING IN QUITTING TOBACCO HABIT

EFFECTIVENESS OF NICOTINE REPLACEMENT THERAPY AND BEHAVIOURAL INTERVENTION IN TOBACCO CESSATION - A TERTIARY HOSPITAL BASED RANDOMISED CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/10/037366
Enrollment
150
Registered
2021-10-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Nicotine patch and Behavioural intervention: Nicotine patch therapy for maximum period of 12 weeks depending on tobacco consumption along with 12 months behavioural counselling Interven

Sponsors

Cipla Pharmaceutical Company
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Individuals more than 18years of age using smoke or smokeless form of tobacco with high or moderate dependency based on modified Fagerstrom scoring criteria and residing within 100Km from the institution.

Exclusion criteria

Exclusion criteria: Tobacco users with unstable angina, severe cardiac arrhythmia, recent acute myocardial infarction or cerebrovascular accident in preceding 3 months, pregnant and breast feeding women and tobacco users with a previous history of failure to NRT will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
tobacco abstinence rateTimepoint: 6 months and 12 months

Secondary

MeasureTime frame
comparing effect of different therapies on cessation of smoking and smokeless tobacco.Timepoint: 6 months and 12 months;the oral health statusTimepoint: baseline, 3 months, 6 months & 12 months;tobacco dependencyTimepoint: baseline, 3 months, 6 months and 12 months

Countries

India

Contacts

Public ContactDr Utkal Keshari Mohanty

S.C.B Dental College and Hospital

utkalcommunity@gmail.com9437953285

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026